TDF/FTC (Truvada) is the only ARV combination currently approved by the FDA for use as preexposure prophylaxis (PrEP). The multinational Phase 3 DISCOVER Study compared the efficacy and safety of TAF/FTC (Descovy) with TDF/FTC, in HIV-uninfected cisgender MSM and transgender women at high risk...

In April 2019, the U.S. Food and Drug Administration approved a combination pill comprising the integrase inhibitor dolutegravir (DTG), 50 mg, and the NRTI lamivudine (3TC), 300 mg, for use as a complete ARV regimen for initial HIV treatment of patients. The approval specifies...

Immediate antiretroviral therapy (ART) refers to starting HIV treatment as soon as possible after the diagnosis of HIV infection, preferably on the first clinic visit (and even on the same day the HIV diagnosis is made). This strategy also is known as "rapid ART," "same-day ART," and "treatment...

The U.S. Food and Drug Administration has approved the NNRTI doravirine for use in initial HIV therapy. FDA approval was based on 48-week results of 2 Phase III studies in treatment-naive persons that showed doravirine + 2 NRTIs resulted in similar rates of viral suppression at 48...

Integrase inhibitors have become primary treatment for most people living with HIV; however, the impact of newer integrase inhibitors on pregnancy outcomes has not been well described. Researchers for the observational Tsepamo study have been examining birth outcomes in Botswanan...

Although DTG currently is not a desirable medication for women to take pre-conception (see Dolutegravir in Early Pregnancy: Updates on Possible Risk of Neural Tube Defects), findings from the DolPHIN study suggest that it may be a very useful agent for women who start ART during...

It's easier than ever to stay on target. The Health Resources and Services Administration's (HRSA) Ryan White HIV/AIDS Program (RWHAP) technical assistance (TA) and training website has undergone a major update to make it easier for users to access tools and materials for the RWHAP. The website...

PARTNER1, whose results were reported last year,(1) was one of the studies that supported current efforts to promote the growing scientific consensus supporting "Treatment as Prevention" (TasP) or Undetectable = Untransmittable (U=U).

As we have commented in the past, initial ARV regimens consisting of 2 drugs tend to perform poorly in comparison with currently recommended 3-drug regimens. Yet, given toxicity concerns about some ARVs (particularly about tenofovir DF and abacavir) and cost concerns about 3-drug regimens, the...

The U.S. Food and Drug Administration has given approval to a coformulation of darunavir 800 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide (TAF) 10 mg, to be marketed under the brand name Symtuza. DRV/COBI/FTC/TAF constitutes a complete regimen for patients with...

On May 18, 2018, the U.S. Food and Drug Administration and the World Health Organization announced that cases of neural tube defects have been reported in babies of women with HIV who were on treatment with dolutegravir at the time of conception and during early pregnancy. The...

Ibalizumab (TNX-355), an entry inhibitor, has been approved by the FDA for use in persons with an extensive ARV treatment history and multidrug resistant HIV who are on a failing ARV regimen. Ibalizumab (trade name: Trogarzo) is a monoclonal antibody that binds the CD4 receptor and blocks HIV...

Bictegravir (BIC), a new integrase inhibitor, was recently approved by the FDA for use in a single-pill coformulation with TAF/FTC (brand name: Biktarvy) as initial therapy and as a switch regimen for patients who are already on a suppressive ART regimen and who have no history of...

Treatment of tuberculosis (TB) in HIV-infected persons remains challenging, in part because of drug interactions between rifampin and some ARVs that may compromise antiretroviral therapy (ART). Three studies presented at CROI provide clinicians with additional guidance on how to manage certain...

The single-pill combination of bictegravir (BIC) with tenofovir alafenamide (TAF) and emtricitabine (FTC), recently approved by the FDA, has been shown in four Phase III trials to be effective as initial therapy and as a switch regimen in patients with stably suppressed HIV RNA...

The availability of ART immediately after the diagnosis of HIV offers many possible benefits, including earlier engagement in care and earlier HIV suppression, which may result in personal and public health benefits. Based on randomized clinical trials done in developing-world settings, the...

The EMERALD Study is a Phase III, open-label, noninferiority study in which 1,141 patients with stable HIV suppression on a regimen comprising a boosted protease inhibitor plus TDF/FTC were randomized (2:1) to either switch to an investigational single-tablet regimen containing...

Release from correctional settings is a high-stakes time for persons with HIV, as it is for those with other health issues. People with substance use disorders often relapse, and those with HIV often stop ART and do not engage in HIV care, increasing the risk of declines in...

In September 2017, the U.S. Centers for Disease Control and Prevention (CDC) officially recognized that suppressing HIV through antiretroviral therapy (ART) prevents sexual transmission of HIV. In a "Dear Colleague" letter, CDC officials said, "people who take ART daily as prescribed and...

Doravirine (DOR) is an investigational NNRTI that currently is being developed in a coformulation with TDF and FTC. A Phase 3 comparison of DOR + 2 NRTIs (87% of study subjects were given TDF/FTC) and DRV/r + 2 NRTIs in initial therapy was presented at CROI earlier this year (DRIVE-FORWARD); the...

Bictegravir (BIC) is an investigational integrase inhibitor that is being studied as part of a coformulation with tenofovir alafenamide (TAF) and emtricitabine (FTC). Two Phase 3 trials comparing a single-tablet regimen of BIC/TAF/FTC (50/25/200 mg) with regimens containing dolutegravir (DTG)...

In recent years, a number of studies have evaluated 2-drug or even 1-drug ARV regimens, either in initial therapy or in switch regimens for patients with virologic suppression on 3-drug therapy. In general, these have not been as successful in achieving or maintaining virologic suppression as...

Leading up to this year, some researchers and clinicians had optimistically viewed dolutegravir an invincible ARV, a drug so mighty that it was unlikely to fail, and even more unlikely to be victim to emergent resistance mutations. Two presentations at CROI demonstrated the...

Doravirine is an investigational NNRTI that is active in vitro against many common NNRTI resistance mutations (including K103N, Y181C, and E138K). It is given once daily, has no food restrictions, and can be given with acid-blocking medications. In a Phase 2 study of treatment-...

Bictegravir is an investigational integrase inhibitor that is dosed once daily, unboosted. It is active in vitro against many viruses with integrase resistance mutations. A Phase 2 double-blind placebo-controlled study randomized treatment-naive patients (n...

At the ASM Microbe meeting in June, researchers from Gilead Sciences presented data on use of TDF/FTC (Truvada) PrEP in the United States according to sex and race. They evaluated national pharmacy databases to identify prescriptions of TDF/FTC given for PrEP between January 2012 and September...

This publication presents the results of San Francisco General Hospital's Ward 86 pilot study of immediate ART initiation. This RAPID program systematically offered ART to patients upon diagnosis of HIV; patients were referred from HIV testing sites in San Francisco. Of the 39 patients who...

I have been working on website accessibility for many years in my role as Production Manager at the UCSF Center for HIV Information. Despite that experience, I still encounter problems that confound me. I recently reached out to an accessibility expert for ideas on how to manage a particularly...

Tenofovir disoproxil fumarate (TDF) may cause decreases in bone mineral density (BMD) both in HIV-infected patients treated with TDF-containing ARV regimens and in HIV-uninfected persons who use it for PrEP. A substudy of the large iPrEx trial of TDF/FTC PrEP in MSM and transgender women...

Dolutegravir has several characteristics that, in theory, suggest it will not be significantly removed by dialysis: It has a large apparent volume of distribution (17.4 L) and is highly protein bound (98.9%). A small study of 5 HIV-infected patients with end-stage renal disease undergoing...

Three studies presented at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) explored the pharmacokinetics of antiretrovirals administered during pregnancy. These studies support the use of standard-dose efavirenz, once-daily dolutegravir, and BID ritonavir-boosted...

Researchers at the 2016 Conference on Retroviruses and Opportunistic Infections presented results from a randomized double-blind, double-dummy switch study of TAF/FTC. Over 660 patients with virologic suppression on TDF/FTC-containing 3-drug regimens were either switched to TAF/FTC (200/10 mg...

A pharmacokinetic study presented at the Conference on Retroviruses and Opportunistic Infections in Boston in February evaluated concentrations of tenofovir (TFV) and TFV-diphosphate (DP) in genital and rectal tissue and in anogenital fluid samples after administration of oral tenofovir...

The prevailing opinion among experts regarding the optimal CD4 T-cell count at which to start patients on antiretroviral therapy (ART) has shifted several times during the evolution of HIV treatment. These shifts reflect attempts to strike a balance between preventing HIV-associated illness and...

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This project is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under grant number U1OHA28686 (AIDS Education and Training Centers National Coordinating Resource Center) awarded to the François-Xavier Bagnoud Center, Rutgers University School of Nursing. No percentage of this project was financed with non-governmental sources. This information or content and conclusions are those of the authors and should not be construed as the official position or policy of, nor should any endorsements be inferred by HRSA, HHS, or the U.S. Government.